Safety Issues
This article was originally published in SRA
Executive Summary
US patient group urges FDA to press on with UDI system for devices
US patient group urges FDA to press on with UDI system for devices
A patient safety group in the US has written to the Food and Drug Administration asking the agency to specify precisely when it intends to promulgate a rule on developing a unique identification system for medical devices1,2. The Advancing Patient Safety Coalition notes that the unique device identification system, which is expected to help reduce medical errors, facilitate recalls and improve adverse event reporting, is a mandatory requirement under the FDA Amendments Act of 2007.
The FDA said last month that it would shortly begin developing draft regulations to implement the system3. The coalition wants the agency to press on with the matter and to also issue a timeline on when the rule will be in place.
The coalition, which comprises hospital, physician, nursing, research, quality and patient advocacy organisations, feels that a national UDI standard has great potential for the entire healthcare system. “It will improve patient safety while increasing efficiency for manufacturers by reducing the potential for counterfeit products being used on a patient. A UDI standard would also help contribute to the success of EHRs [electronic health records] and improve patient care by providing appropriate healthcare providers with accurate information,” the coalition wrote in its letter to FDA commissioner Andrew von Eschenbach.
When implemented, the new system will require:
- the label of a device to bear a unique identifier, unless an alternative location is specified by the FDA or unless an exception is made for a particular device or group of devices;
- identification of the device throughout distribution and use; and
- inclusion of a lot or serial number if specified by the FDA.
In October last year, the FDA held a public meeting with over 150 attendees to discuss the issues associated with the development, implementation and use of a UDI system and the use of various automatic identification technologies. The discussion centred on the challenge of developing standard data requirements in a world of many already existing systems.
Currently there is no standardised unique identification system for medical devices, which makes it difficult to recognise compatibility and interoperability issues, to conduct recalls and to identify specific devices in adverse event reports4. The need for such a system is important in light of the rising number of medical device recalls as well as rapid development of new and complex devices.
As the FDA develops the proposed regulation, it is examining the results of the public meeting as well as comments it received following the 2006 publication of a Federal Register notice on the issue.
References
1. American Hospital Association press release, 1 April 2008, www.ahanews.com/ahanews_app/jsp/display.jsp?dcrpath=AHANEWS/AHANewsNowArticle/data/ann_080401_FDA&domain=AHANEWS
2. Advancing Patient Safety Coalition letter to FDA, 26 March 2008, www.aha.org/aha/letter/2008/080401-let-patient-safety-fda.pdf
3. FDA, Unique Device Identification, 20 March 2008, www.fda.gov/cdrh/ocd/udi/
4. FDA, House, Senate Conference Report and Appropriations Bill Significant Items, 2 February 2008, www.fda.gov/oc/oms/ofm/budget/2009/Supptables/Significant_Items.pdf